It’s safe... but if you have had a headache for 4 days seek help
THE Oxford vaccine is highly effective and does not increase the risk of blood clots, British and European medical regulators said last night.
They insisted there was no evidence the jab – which had been suspended by several European nations – increased the risk of blood clots.
However they revealed they were investigating cases of a rare clotting disorder in the brain among Oxford AstraZeneca patients, including five – involving one death – in Britain.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said anyone who had suffered a headache for four days after their vaccine, or developed unusual bruising, should seek medical advice.
The European Medical Agency (EMA) said it had investigated
‘Benefits outweigh the risks’
reports that the jab was linked to clots, but found no evidence to support this claim.
It concluding the jab was ‘safe and effective’ and that overall levels of blood clots were actually lower among people who have been vaccinated.
However, the EMA said it had identified 18 cases of a rare blood clotting disorder in the brain, called Cerebral Venous Sinus Thrombosis ( CVST), which they said ‘ could not definitively’ be ruled out as having a link to the AZ vaccine.
The five British cases were in men aged 19 to 59. The MHRA said it was thoroughly examining the ‘extremely rare possible side effect’.
CVST is an extremely rare type of stroke. It occurs when the vein that drains blood from the brain is blocked by a blood clot, resulting in potentially deadly bleeding on the brain.
Cases are so rare that it is difficult to establish how many would have been expected in an unvaccinated population. The blood clots could also have been caused by Covid.
Even if the vaccine was found to be causing CVST, it still occurs in less than one in a million people who have been vaccinated. The risk of dying from Covid is about 1,000 times higher. Officials are carrying out detailed investigations into each case, to try to establish whether there is a link.
Last night officials moved to reassure patients that the benefits of the vaccine hugely outweigh the potential risk.
Boris Johnson said he would be getting AZ vaccine today, adding: ‘The Oxford jab is safe, the Pfizer jab is safe. The only thing that isn’t safe is catching Covid.’ Dr June Raine, MHRA chief executive, said the link between the cases of CSVT and the vaccine is ‘unproven’.
She added: ‘The benefits of the vaccine in preventing Covid-19... continue to outweigh the risks of potential side effects. You should therefore continue to get your jab when it is your turn.’
Emer Cooke, head of the EMA, said: ‘This is a safe and effective vaccine. Its benefits in protecting people from Covid19, with the associated risks of death and hospitalisation, outweigh the possible risks.’
Professor Andrew Pollard, head of the Oxford Vaccine Trial, said: ‘I welcome the news that both the MHRA and EMA have reiterated that the vaccine’s benefits continue to outweigh any potential risks, and the vaccine should continue to be administered.
‘The rate of Covid is rising in many countries on the continent and vaccination remains a central component of our fight against the pandemic virus.’